DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to because they fail to meet the standard for drawings set forth in 37 C.F.R 1.84 which require all numbers, letters, and reference characters in the drawings to measure at least 0.32 cm (1/8 inch) in height and requires that no text be placed upon shaded surfaces. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-6, 9, 10, 12-21 and 23 are objected to because of the following informalities:
Claim 1: Claim 1 is grammatically incorrect. In order to be grammatically correct, (1) the commas on lines 5, 19 (the first comma), 36, 40, 48, 49, 54, and 70 should be removed, (2) the term “and” should be inserted after the second comma on line 24 and after the semi-colon on line 25, and (3), the each occurrence of the term “rotates” on lines 64 and 65 should be replaced with the term “rotate”.
Claim 2: Claim 2 is grammatically incorrect. In order to be grammatically correct, the second comma on line 3 and the comma on line 7 should be removed. The phrase “the step of” should be inserted before the phrase “the wheel actuator” on line 3 and the term “rotates” on line 3 should be replaced with the term “rotating” since this step has already been introduced in claim 1.
Claim 3: Claim 3 is grammatically incorrect. In order to be grammatically correct, the first comma on line 4 and the comma on line 5 should be removed.
Claim 4: Claim 4 is grammatically incorrect. In order to be grammatically correct, the second comma on line 3 and the comma on line 8 should be removed. The phrase “the step of” should be inserted before the phrase “the wheel actuator” on line 3 and the term “rotates” on line 3 should be replaced with the term “rotating” since this step has already been introduced in claim 1.
Claim 5: Claim 5 is grammatically incorrect. In order to be grammatically correct, the first comma on line 5 and the comma on line 6 should be removed.
Claim 6: Claim 6 is grammatically incorrect. In order to be grammatically correct, the comma on line 2 should be removed.
Claim 9: The phrase “switching mechanism” on line 2 lacks an article preceding it; since this feature was introduced in claim 1, the term “the” should be inserted before this phrase. On term “linear” on line 3 has been misspelled as “liner”.
Claim 10: The term “solenoid” on line 4 should not be capitalized.
Claim 12: Claim 12 is grammatically incorrect. In order to be grammatically correct, (1) the commas on lines 9, 17, 28 and 41 (both) should be removed and (2) each occurrence of the term “rotates” on lines 35 and 37 should be replaced with the term “rotate”. The phrase “the Piston Drive Member (PDM)” on lines 17-18 should be replaced with the phrase “the PDM” since this feature has already been introduced earlier in the claim. The phrases “the second kinetic pathway step” on line 21, “the low linear resolution mode” on lines 21-22, “the first gear” on line 34, “the second gear” on line 36, “the third gear” on line 36, and “the barrel” on line 43 each lack proper antecedent basis since this is the first time they are being introduced in the claim; the term “the” in each of these phrases should be replaced with the term “a” or the term “an”.
Claim 13: Claim 13 is grammatically incorrect. In order to be grammatically correct, the commas on lines 3 and 8 should be removed. The phrase “the step of” should be inserted before the phrase “the wheel actuator” on lines 2-3 and the term “rotates” on line 3 should be replaced with the term “rotating” since this step has already been introduced in claim 12.
Claim 14: Claim 14 is grammatically incorrect. In order to be grammatically correct, (1) the term “rotates” on line 4 should be replaced with the term “rotate” and (2) the comma on line 5 should be removed.
Claim 15: Claim 15 is grammatically incorrect. In order to be grammatically correct, the commas on lines 3 and 7 should be removed. The phrase “the step of” should be inserted before the phrase “the wheel actuator” on lines 2-3 and the term “rotates” on line 3 should be replaced with the term “rotating” since this step has already been introduced in claim 1.
Claim 16: Claim 16 is grammatically incorrect. In order to be grammatically correct, the comma on line 4 and the second comma on line 5 should be removed.
Claim 17: Claim 17 is grammatically incorrect. In order to be grammatically correct, the second comma on line 1 should be removed.
Claim 18: The phrase “the secondary shaft” on line 2 lacks proper antecedent basis; since this is the first time this feature is being introduced, the term “the” should be replaced with the term “a”.
Claim 19: Claim 19 is grammatically incorrect. In order to be grammatically correct, the comma on line 2 should be removed.
Claim 20: The term “linear” on line 3 has been misspelled as “liner”. The term “solenoid” on line 3 should not be capitalized.
Claim 21: The term “solenoid” on line 3 should not be capitalized.
Claim 23: Claim 21 is grammatically incorrect. In order to be grammatically correct, (1) the commas on lines 5, 17 (the first comma), 18, 38, 45, 47 51, 55 and 67 should be removed, (2) the term “and” should be inserted after the second comma on line 22 and after the semi-colon on line 23, (3) the term “an” should be inserted before the term “angle” on line 45, (4) each occurrence of the term “rotates” on lines 61 and 62 should be replaced with the term “rotate” and (5) a comma should be inserted after the term “respectively” on line 69. The term “a” in each of the phrases “a first kinematic pathway” on line 31, “a high linear resolution mode” on line 31, “a Piston Drive Member (PDM)” on lines 31-32, “a switching mechanism” on line 33, “a second clutch” on lines 33-34, “a third clutch” on line 34, “a fourth clutch” on line 34, “a first clutch” on lines 34-35, “a motor” on line 36, “a primary shaft” on line 37, “a threaded rotatable shaft” on line 42, “a plunger” on line 44, “a syringe” on line 44, “a fluid” on line 47, “a low linear resolution mode” on line 48, “a Compliant Ratchet Actuator (CRA)” on line 54, “a barrel” on line 67, “a syringe” on lines 67-68, and “a removable fluid delivery tube” on line 68 should be replaced with the term “the” since each of these features has been introduced earlier in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11, 17, 20, 23 and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite for the following reasons:
The preamble of claim 1 only functionally recites “a syringe” having “a barrel”, “a plunger” and “a removable fluid delivery tube” (see lines 1-3), but lines 5 and 20 appear to positively recite the syringe and its components in the phrases “a driving unit removably coupled to the syringe” and “wherein the PDM linearly advances the plunger of the syringe”, respectively. Because the syringe and its components are first functionally recited but then later positively recited, it is unclear if the syringe and its components are intended to be a part of the claimed “scalable fluid delivery apparatus” or not. For the sake of examination, they are not interpreted as a part of the claimed invention. Accordingly, it is suggested to amend line 5 to recite “a driving unit configured to be removably coupled to the syringe” and to amend line 20 to recite “wherein the PDM is configured to linearly advance[[s]] the plunger of the syringe”.
Lines 18-19 recite “a threaded rotatable shaft rigidly coupled via a first end to the third clutch and removably coupled via a second end to a Piston Drive Member (PDM)”. As written, it is unclear if the “first end” belongs to the “threaded rotatable shaft” or to the “third clutch” and if the “second end” belongs to the “threaded rotatable shaft” or to the “Piston Drive Member (PDM)”. For the sake of examination, both ends are interpreted as belonging to the threaded rotatable shaft. Accordingly, it is suggested to amend lines 18-19 to recite “a threaded rotatable shaft comprising a first end rigidly coupled a second end removably coupled
Line 20 recites “wherein the PDM [is configured to] linearly advance[[s]] the plunger of the syringe when in contact”. As written, it is unclear if the contact is performed by the “PDM” or b the “plunger of the syringe” and what the contact is with. For the sake of examination, the contact is interpreted as being between the PDM and the plunger of the syringe. Accordingly, it is suggested to amend line 20 to recite “wherein the PDM [is configured to] linearly advance[[s]] the plunger of the syringe when the PDM contacts the plunger of the syringe”.
Claims 2-11 and 24 are rejected due to their dependence on claim 1.
Claim 6 recites “wherein[[,]] the PDM is constrained by a sliding joint with a non-circular cross section, wherein the non-circular cross-section of the sliding joint does not allow the sliding joint to rotate upon rotation of the threaded rotatable shaft or the third clutch, and only moves linearly” on lines 2-5. As written, it is unclear what feature – the PDM or the sliding joint – “only moves linearly”. For the sake of examination, the limitation is interpreted such that it is the “sliding joint” that “only moves linearly”. Accordingly, it is suggested to amend claim 6 to recite “wherein[[,]] the PDM is constrained by a sliding joint with a non-circular cross section, wherein the non-circular cross-section of the sliding joint does not allow the sliding joint to rotate upon rotation of the threaded rotatable shaft or the third clutch[[,]] and allows the sliding joint to only move[[s]] linearly”.
Claim 9 recites “wherein the MAD and [the] switching mechanism comprises at least one of a motor, a linear motor, a liner actuator, a Shape Memory Allow (SMA), and a Solenoid” on lines 2-3. As written, it is unclear if each of the MAD and the switching mechanism are required to comprises at least one of the features listed or if the combination of the MAD and the switching mechanism are required to comprise at least one of the features listed. It is not clear from the Specification which of the two interpretations set forth above are the intended interpretation; Accordingly, the Examiner does not have a suggestion for how to amend claim 9 to overcome this rejection.
Claim 17 recites “wherein[[,]] the PDM is constrained by a sliding joint with a non-circular cross section, wherein the non-circular cross-section of the sliding joint does not allow the sliding joint to rotate upon rotation of the threaded rotatable shaft or the third clutch and only moves linearly” on lines 2-5. As written, it is unclear what feature – the PDM or the sliding joint – “only moves linearly”. For the sake of examination, the limitation is interpreted such that it is the “sliding joint” that “only moves linearly”. Accordingly, it is suggested to amend claim 17 to recite “wherein[[,]] the PDM is constrained by a sliding joint with a non-circular cross section, wherein the non-circular cross-section of the sliding joint does not allow the sliding joint to rotate upon rotation of the threaded rotatable shaft or the third clutch and allows the sliding joint to only move[[s]] linearly”.
Claim 20 recites “wherein the MAD and the switching mechanism comprises at least one of a motor, a linear motor, a liner actuator, a Shape Memory Allow (SMA), and a Solenoid” on lines 2-3. As written, it is unclear if each of the MAD and the switching mechanism are required to comprises at least one of the features listed or if the combination of the MAD and the switching mechanism are required to comprise at least one of the features listed. It is not clear from the Specification which of the two interpretations set forth above are the intended interpretation; Accordingly, the Examiner does not have a suggestion for how to amend claim 20 to overcome this rejection.
Claim 23 is indefinite for the following reasons:
The preamble of claim 23 only functionally recites “a syringe” having “a barrel”, “a plunger” and “a removable fluid delivery tube” (see lines 1-3), but lines 5 and 18 appear to positively recite the syringe and its components in the phrases “a driving unit removably coupled to the syringe” and “wherein the PDM linearly advances the plunger of the syringe”, respectively. Because the syringe and its components are first functionally recited but then later positively recited, it is unclear if the syringe and its components are intended to be a part of the claimed “scalable fluid delivery apparatus” or not. For the sake of examination, they are not interpreted as a part of the claimed invention. Accordingly, it is suggested to amend line 5 to recite “a driving unit configured to be removably coupled to the syringe” and to amend line 28 to recite “wherein the PDM is configured to linearly advance[[s]] the plunger of the syringe”.
Lines 17-18 recite “a threaded rotatable shaft rigidly coupled via a first end to the third clutch and removably coupled via a second end to a Piston Drive Member (PDM)”. As written, it is unclear if the “first end” belongs to the “threaded rotatable shaft” or to the “third clutch” and if the “second end” belongs to the “threaded rotatable shaft” or to the “Piston Drive Member (PDM)”. For the sake of examination, both ends are interpreted as belonging to the threaded rotatable shaft. Accordingly, it is suggested to amend lines 17-18 to recite “a threaded rotatable shaft comprising a first end rigidly coupled a second end removably coupled
Line 18 recites “wherein the PDM [is configured to] linearly advance[[s]] the plunger of the syringe when in contact”. As written, it is unclear if the contact is performed by the “PDM” or by the “plunger of the syringe” and what the contact is with. For the sake of examination, the contact is interpreted as being between the PDM and the plunger of the syringe. Accordingly, it is suggested to amend line 18 to recite “wherein the PDM [is configured to] linearly advance[[s]] the plunger of the syringe when the PDM contacts the plunger of the syringe”.
Allowable Subject Matter
Claims 1-24 would be allowable if rewritten or amended to overcome the objections and/or the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of the independent claims could not be found nor was suggested in the prior art of record.
Independent claim 1 requires a scalable fluid delivery apparatus comprising (A) a motion actuating device and (B) a driving until comprising (i) a primary shaft, (ii) a secondary shaft, (iii) a wheel actuator mounted on the secondary shaft, comprising a ratchet wheel or an indexed wheel, and being at least one of a compliant ratchet actuator, a compliant indexed wheel actuator, a rigid linkages, and a rigid actuator, (iv) a first clutch on the primary shaft, (v) a second clutch mounted on the secondary shaft, (vi) a third clutch mounted adjacent the second clutch, (vii) a fourth clutch mounted adjacent the first clutch, (viii) a piston drive member, (ix) a threaded rotatable shaft rigidly coupled its first end to the third clutch and removably coupled at its second end to the piston drive member, (x) a first gear rigidly coupled to the third clutch, (xi) a third gear coupled to the fourth clutch, (xii) a second gear coupled to the first gear and the third gear, and (xiii) a switching mechanism, wherein the motion actuation device is configured to transmit motion in (1) a first kinematic pathway corresponding to a high linear resolution mode of the piston drive member and (2) a second kinematic pathway corresponding to a low linear resolution mode of the piston drive member in order to deliver fluid from a syringe. Claim 1 also details the steps of the two kinematic pathways that the motion actuation device must be configured to transmit motion in, with (1) the first kinematic pathway comprising steps of (a) receiving an actuation from the switching mechanism to engage the second and third clutches and to disengage the first and fourth clutches, (b) performing an actuation by the motion actuation device to transmit motion to the wheel actuator such that the wheel actuator incrementally rotates the ratchet/indexed wheel based on a type of coupling between the motion actuation device and the wheel actuator, (c) rotating the engaged second and third clutches equivalent to an amount of rotation of the ratchet/indexed wheel, wherein the third clutch and the threaded rotatable shaft rotate equivalent to an amount of rotation of the second clutch, (d) pushing a plunger of a syringe by a distance corresponding to a lead of the threaded rotatable shaft and an angle of rotation of the third clutch to create a linear motion at the piston drive member, (e) and delivering fluid in the syringe, and (2) the second kinematic pathway comprising steps of (f) receiving an actuation from the switching mechanism to disengage the second and third clutches and to engage the first and fourth clutches, (g) performing an actuation by the motion actuation device to transmit motion to the wheel actuator such that the wheel actuator incrementally rotates the ratchet/indexed wheel based on a type of coupling between the motion actuation device and the wheel actuator, (h) rotating the first and fourth clutches equivalent to an amount of motion of the motion actuation device, (j) transmitting rotation of the fourth clutch to the third clutch, wherein the first gear, the third clutch and the threaded rotatable shaft rotate based on rotation transmitted from the second and third gears, wherein the third clutch and the threaded rotatable shaft rotate equivalent to an amount of a gear ratio of the third and first gears or to an amount of an arbitrary ratio based on a gear train configuration, (k) and performing a forward or reverse motion on the piston drive member corresponding to a lead and an angle of rotation of the third clutch and the rotatable shaft, wherein the forward motion is for priming the a barrel and a removable fluid delivery tube of the syringe or for delivering fluid and the reverse motion is for reverting the piston drive member to an initial position or to deliver the fluid. The prior art of record does not disclose or teach an apparatus comprising all of the above listed structural components such that they are arranged in the manner claimed to be functionally able to perform the functionally recited steps. Therefore, it is the combination of structural features and the functional requirements that must be met by their arrangement that forms the basis for allowance.
Independent claim 12 requires a method for scalable fluid delivery comprising the first and second kinematic pathway steps only functionally recited in claim 1 (see above). The prior art of record does not disclose or teach a method of performing all of the steps recited above. Therefore, it is the combination of steps and the structural elements that perform these steps that forms the basis for allowance.
Independent claim 23 requires a scalable fluid delivery apparatus substantially similar to that of claim 1 except additionally requiring an eccentric cam attached to the primary shaft, requiring items (A) and (iii) to be more narrow than in claim 1, and require steps (b), (d) and (h) to differ from those in claim 1 due to them corresponding to the eccentric cam and items (A) and (iii). Specifically, claim 23 requires (A) a motor (instead of just (A) a motion actuating device) and requires (iii) a compliant ratchet actuator comprising a ratchet wheel (instead of just (iii) a wheel actuator mounted on the secondary shaft, comprising a ratchet wheel or an indexed wheel, and being at least one of a compliant ratchet actuator, a compliant indexed wheel actuator, a rigid linkages, and a rigid actuator); additionally, claim 23 requires the piston drive member to be configured to (b) perform an actuation by the motor to transmit a rotational motion to the compliant ratchet actuator via the eccentric cam such that the compliant ratchet actuator incrementally rotates the ratchet wheel based on an eccentricity of the eccentric cam (instead of (b) perform an actuation by the motion actuation device to transmit motion to the wheel actuator such that the wheel actuator incrementally rotates the ratchet/indexed wheel based on a type of coupling between the motion actuation device and the wheel actuator), (g) perform an actuation by the motor to transmit rotational motion to the compliant ratchet actuator via the eccentric cam such that the compliant ratchet actuator incrementally rotates the ratchet wheel based on the eccentricity of the eccentric cam (instead of (g) perform an actuation by the motion actuation device to transmit motion to the wheel actuator such that the wheel actuator incrementally rotates the ratchet/indexed wheel based on a type of coupling between the motion actuation device and the wheel actuator), and (h) rotate the engaged first and fourth clutches equivalent to an amount of rotation of the motor (instead of (h) rotate the first and fourth clutches equivalent to an amount of motion of the motion actuation device). The prior art of record does not disclose or teach an apparatus comprising all of the above listed structural components such that they are arranged in the manner claimed to be functionally able to perform the functionally recited steps. Therefore, it is the combination of structural features and the functional requirements that must be met by their arrangement that forms the basis for allowance.
Relevant prior art of record includes Cowan et al. (PG PUB 2006/0184124), Dai et al. (PG PUB 2007/0060894), Kjeldsen et al. (PG PUB 2015/0105732), and Gabriel et al. (PG PUB 2019/0091412) but none of these references alone or in combination teach the subject matter of the independent claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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